Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003902955

FEI Number

3003902955

Entity Name

TERUMO (PHILIPPINES) CORPORATION

City/State/Country

BINAN Laguna, PH

Establishment Address

No. 124 EAST MAIN AVE., LAGUNA TECHNOPARK, BINAN Laguna 4024, PH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terumo (Philippines) Corporation (Owner Number: 10033966)

Owner / Operator Contact Address

NO. 124 East Main Ave.,, Laguna Technopark, Binan, PH-LAG 4024, PH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152362

PMA Number

N/A

All Registered Proprietary Names

Terumo® SurGuard® 3 Hypodermic Syringe with Safety Needle Terumo® SurGuard® 3 Safety Hypodermic Needle McKesson Medi-Pak¿ Performance Needle Terumo® Needle Terumo® Syringe tuberculin with needle Terumo® Syringe tuberculin without needle Terumo® Syringe with needle Terumo® Syringe without needle Terumo® Syringe Pharmacy Tray Terumo SurGuard3 Safety Hypodermic Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2012-03-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-03-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-11-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-10-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-10-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Business: Terumo Medical Corp. Email: dina.justice@terumomedical.com Phone: (410) 3927226

Related Public Records

Same Entity

Terumo (Philippines) Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902955. Last updated year: 2026. Please use registration number 3003902955 when referencing this establishment in official correspondence.